Product Wiki · Recalls · U.S. FDA — Device Enforcement

Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities — recall Z-0073-2017

U.S. FDA — Device Enforcement · United States · 2016-09-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0073-2017
Date of alert
2016-09-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fujifilm Medical Systems U.S.A., Inc.
Product category
device
Product type
Devices
Reported risk: Image data for a patients image may not be correct
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.